Job Description
The successful candidate will be responsible for the management and leadership of the Quality Systems Operation function. As part of the QA Operations Site Management Team, you will be a key leader in the cross-functional support of cGMP compliance activities and will be immersed in Quality Systems for the site to identify potential risks and trends and to support during regulatory inspections and internal audits. This role will provide Quality and Compliance oversight across manufacturing, quality control, quality assurance, technical operations, materials management, and validation.As the Associate Director Quality Systems, a typical day might include, but is not limited to, the following:Overseeing Quality Systems Operations, processing and directing the activities of the Quality Systems management team.Owning and continuously improving the Quality Management Systems including but not limited to deviations, CAPAs, and change controls.Providing technical guidance and building technical capability within the team.Ensuring compliance with all aspects of quality for the site inclusive of manufacturing, quality systems, quality control, validation, technical operations, and materials management.Ensuring alignment is maintained and achieved across the manufacturing sites for areas of responsibility.Providing technical expertise and leadership with respect to cGMP across the site, quality systems, investigations, changes, and other areas, as required.Interacting with critical biotechnology commercial API manufacturing operations facilities to ensure a successful compliance profile.Defining and implementing quality standards, systems, and metrics.Ensuring that products adhere to tight internal standards as well as those of the agencies that regulate the pharmaceutical industry around the world.Supporting in aspects of Regulatory Agency interactions and preparation as related to site inspections, and ensuring regulatory observations are adequately addressed and completed on schedule.Partnering with critical contract manufacturers to resolve compliance issues in commercial and clinical supply chains, interfaces with customer/partner quality organizations, and negotiates third-party contractor and supplier quality agreements.Authorizing significant deviations to established, approved procedures, providing guidance to assist co-workers with troubleshooting investigations and problem resolution.Ensuring safety and operational standards are maintained.This role might be for you if you:Maintain integrity and honesty at all times.Communicate with transparency.Have a strong background and are familiar with site change control, risk management, and data integrity initiatives/programs.Are a passionate leader who can drive and motivate employees.Continuously drive processes for improved performance.To be considered for this position, you must hold a BS or higher in life sciences with 10+ years of relevant experience in QA within the Pharma/Biopharma Industry. You must have at least 5 years of people management experience. #J-18808-Ljbffr